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PLATINUM: Anti-malarial Agents in Uncomplicated P. falciparum Malaria
NCT05750628Phase 2
Key facts
- Status
- Recruiting
- Start
- Jan 2024
- Primary completion
- Jun 2026
- Countries
- 6
- Sponsor
- Novartis
- Modality
- Small Molecules
- Conditions
- Plasmodium falciparum malaria
01
Overview
Phase 2, randomised, open-label trial of INE963, cipargamin and ganaplacide in Plasmodium falciparum malaria (10 cohorts), sponsored by Novartis. Primary endpoints: Parasite Clearance Time at Day 7 and Adequate Clinical and Parasitological Response (PCR-corrected) at Day 29. Started Jan 2024; status: recruiting.
02
Design
10 arms- Study design
- RandomizedOpen-label
Cohort A1: Dose Level 1 INE963
INE963 Monotherapy Dose 1
Cohort A1: Dose Level 2 INE963
INE963 Monotherapy Dose 2
Cohort A1: Dose Level 3 INE963
INE963 Monotherapy Dose 3
Cohort A1: Dose Level 4 INE963
INE963 Monotherapy Dose 4
Cohort B1: Cipargamin + INE963
Combination therapy
Cohort B1: SoC
Standard of Care (Coartem)
4 more in the full profile.
03
Who it enrols
Patients aged 2 years and older with acute uncomplicated P. falciparum malaria mono-infection, confirmed by parasite count, weighing at least 10 kg, and without signs of severe malaria, significant liver disease, or cardiac abnormalities.
04
Endpoints
Primary
Parasite Clearance Time
Adequate Clinical and Parasitological Response (PCR-corrected)
Secondary
Adequate Clinical and Parasitological Response (PCR-corrected and uncorrected)
Area Under the Concentration-Time Curve (Time 0 to Last)
Maximum Observed Concentration
Incidence and Severity of Adverse Events
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